The main idea behind the Italian ACTION (ACcess To Intensive Obstetrical and Neonatal care) follow-up project was to assess the outcomes of every very preterm birth occurring in a given geographical area, as opposed to those cared for in maternities and NICUs of tertiary hospitals only, and to identify factors that could explain such outcomes and suggest possible strategies for improvement. Thus, the initial cohort recruitment in 2003-05 and collection of perinatal data up to hospital discharge involved every hospital and birth centre in five participating Italian regions: one in the North (Friuli Venezia-Giulia, FVG), three in the center (Tuscany, Marche and Lazio) and one in the South (Calabria). Follow-up after discharge from NICU was carried out at 2 years of age corrected for prematurity (ACTION2) in all the 5 regions, and also at school age (ACTION3) in FVG, Tuscany and Lazio. These studies were funded by three subsequent grants of the Italian Ministry of Health; however, follow-up would not have been possible without the additional support of Chiesi Farmaceutici SpA.
The main challenges of the project were the identification of all births at 22 to 31 completed weeks of gestational age, including stillbirths and delivery room deaths and, subsequently, tracing the families for follow-up. Based on the initial written consent by parents to be contacted again for follow-up, we used multiple strategies to trace them such as use of hospitals databases, involvement of family doctors and of the Community Civil Registration centres and regional offices for routine statistics. Follow-up rates were 85% at 2 years and 73 % at school age.
Thanks to the collaboration between obstetricians, midwifes and neonatal physicians and nurses, ACTION was one of the largest studies in Italy collecting both pregnancy obstetrical data and information on NICU morbidities and treatments. This allowed us to assess the relation between maternal problems in pregnancy and infant outcomes, both in terms of neonatal morbidities and of cause of death in NICU.
The involvement of parents themselves in providing data on their child health and development was important. They completed standardized questionnaires to assess verbal and non-verbal development at 2 years, and later to provide information about their children’s health and abilities including medical history, motor coordination, behavioural and emotional problems, eating habits and leisure activities. At school age, the children themselves had the possibility to provide their own perspective by using age-appropriate questionnaires related to their everyday life, relations with peers, and overall quality of life.
One additional feature of the ACTION project was the attention given to the mothers psychological health and to parental distress, that were measured through self-report validated questionnaires both at 2 years corrected age and at school-age of the children. While the impact of preterm birth on parental distress, particularly in case of child disability, has been well documented in the literature, less is known on the influence of maternal distress on parenting styles and child development. While relatively new, research in this area is particularly important at the light of the possible interventions to support parents and improve the wellbeing of the families and the children outcomes.
About 8 years after the starting of the ACTION cohort recruitment, the participation of Italy to the EPICE and SHIPS projects, based on similar sampling strategy and measurements, allowed the comparison of the perinatal and 2-years outcomes in the those regions (Lazio and Marche) that took part in both projects. We confirmed the improvement of survival over time documented in other industrialised countries, while change in neurodevelopmental conditions at 2 years was less clear-cut. These results are reassuring in showing that the organisational and technological improvements in perinatal care are effective to improve survival without increasing subsequent neuromotor and sensory disabilities. They also indicate the feasibility of follow-up to monitor development in Italy, and the importance of implementing it for all very preterm children.
Ospedale Pediatrico Bambino Gesù
Please note: The ACTION is part of the project RECAP preterm which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733280.